MP/CG Update/Notice - January 2023 Form

P.O. Box 4330 Woodland Hills, CA 91365 Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insurance Company are independent licensees of the Blue Cross Association. Anthem is a registered trademark of Anthem Insurance Companies, Inc.

January 1, 2023

Dear Provider:

Anthem Blue Cross (Anthem) is pleased to provide you with our new and updated Medical Policies and Clinical UM Guidelines. Please refer to the specific policy for coding, language, rationale updates and changes that are not summarized below.

NEW Medical Policies

• MED.00135 Gene Therapy for Hemophilia: This document addresses gene therapy for hemophilia, a congenital medical condition in which the blood does not clot normally due to lack of sufficient blood-clotting proteins known as clotting factors. The current document addresses the clinical coverage criteria for the new gene therapy for Hemophilia B (Factor IX deficiency) approved by the FDA on November 22, 2022. o Outlines Medically Necessary and Investigational and Not Medically Necessary criteria o Prior authorization required effective April 1, 2023

• MED.00143 Ingestible Devices for the Treatment of Constipation: This document addresses the use of ingestible devices to mechanically stimulate the colon using vibration to treat constipation. o Considered Investigational and Not Medically Necessary o Prior authorization required effective April 1, 2023

UPDATED Clinical Guidelines and Medical Policies effective April 1, 2023

• CG-DME-31 Powered Wheeled Mobility Devices: This document addresses criteria for powered wheeled mobility devices (also referred to as power mobility devices) including, but are not limited to pediatric and adult powered/motorized wheelchairs, pushrim activated power assist devices, and power operated vehicles (POVs) and powered wheeled mobility devices using a computerized system of sensors, gyroscopes and electric motors to assist with seat elevation and navigation over stairs or uneven terrain. o Added Not Medically Necessary statement for powered wheeled mobility devices using computerized systems of sensors such as to assist with functions such as seat elevation and navigation over curbs, stairs or uneven terrain (for example, the iBOT Personal Mobility Device) for all indications

• GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling*:
This document addresses gene panel testing, whole genome sequencing, whole exome sequencing, molecular profiling, and polygenic risk score testing.
o Moved content from GENE.00037 Genetic Testing for Macular Degeneration and CG-GENE-23 Genetic Testing for Heritable Cardiac Conditions into this document effective December 28, 2022 o Added CPT codes 0205U, 81439 previously addressed in the documents listed above, considered Not Medically Necessary o Added chromosome conformation signatures to scope of document and Investigational and Not Medically Necessary statement o Added CPT PLA code 0332U for the EpiSwitch CiRT (Checkpoint-inhibitor Response Test) considered Investigational and Not Medically Necessary o Added CPT codes 81441, 81449, 81451, 81456 for panels considered Not Medically Necessary o Updated CPT descriptors effective January 1, 2023

*Effective July 1, 2022, in compliance with California SB 535, Anthem Blue Cross and its delegated entities regulated by the California Department of Managed Health Care and the California Department of Insurance will no longer require prior authorization for biomarker testing, including biomarker testing for cancer progression and recurrence, for members with advanced or metastatic stage 3 or 4 cancer. Post service review of medical necessity for biomarker testing for advanced or metastatic stage 3 or 4 cancer members is not permitted, only confirmation of advanced or metastatic stage 3 or 4 cancer is permitted.

• MED.00130 Electrodermal Activity Sensor Devices for Seizure Monitoring: This document addresses devices that use surface electromyography (sEMG) and electrodermal activity sensor devices to monitor seizures.
o Revised title (previously titled Surface Electromyography and Electrodermal Activity Sensor Devices for Seizure Monitoring) o Added electrodermal activity sensor devices as Investigational and Not Medically Necessary o Updated Scope, Rationales, Background/Overview, References and Index sections

• SURG.00097 Scoliosis Surgery: This document addresses surgical treatments for scoliosis, specifically, use of a minimally invasive deformity correction system, vertebral body tethering, and vertebral body stapling. o Added magnetically controlled growing rods to scope of document as Investigational and Not Medically Necessary o Updated Description/Scope, Rationale, Background/Overview, Coding, References, and Index sections

UPDATED Clinical Guideline effective May 1, 2023

• CG-MED-23 Home Health: This document addresses home health care and the conditions under which it would be considered medically necessary. Home health care refers to intermittent skilled health care related services provided by or through a licensed home health agency to an individual in his or her place of residence. o Effective May 1, 2023, all codes will be reviewed for Medical Necessity

Prior Authorization will be required for the following effective April 1, 2023

• ANC.00006 Biomagnetic Therapy • DME.00025 Self-Operated Spinal Unloading Devices • DME.00030 Altered Auditory Feedback Devices for Fluency Disorders • DME.00041 Low Intensity Therapeutic Ultrasound • DME.00042 Electronic Positional Devices for the Treatment of Obstructive Sleep Apnea • GENE.00020 Gene Expression Profile Tests for Multiple Myeloma* (SB 535 exclusion applies)
• LAB.00016 Fecal Analysis in the Diagnosis of Intestinal Disorders • LAB.00024 Immune Cell Function Assay • LAB.00025 Topographic Genotyping • LAB.00026 Systems Pathology Testing for Prostate Cancer • LAB.00028 Serum Biomarker Tests for Multiple Sclerosis • LAB.00036 Multiplex Autoantigen Microarray Testing for Systemic Lupus Erythematosus • LAB.00037 Serologic Testing for Biomarkers of Irritable Bowel Syndrome (IBS)
• LAB.00038 Cell-free DNA Testing to Aid in the Monitoring of Kidney Transplants for Rejection • LAB.00039 Pooled Antibiotic Sensitivity Testing • LAB.00041 Machine Learning Derived Probability Score for Rapid Kidney Function Decline • MED.00053 Non-Invasive Measurement of Left Ventricular End Diastolic Pressure in the Outpatient Setting • MED.00059 Idiopathic Environmental Illness (IEI) • MED.00087 Optical Detection for Screening and Identification of Cervical Cancer • MED.00089 Quantitative Muscle Testing Devices • MED.00091 Rhinophototherapy • MED.00097 Neural Therapy • MED.00098 Hyperoxemic Reperfusion Therapy
• MED.00101 Physiologic Recording of Tremor using Accelerometer(s) and Gyroscope(s) • MED.00102 Ultrafiltration in Decompensated Heart Failure
• MED.00104 Non-invasive Measurement of Advanced Glycation End Products (AGEs) in the Skin • MED.00110 Silver-based Products for Wound and Soft Tissue Applications • MED.00111 Intracardiac Ischemia Monitoring
• MED.00116 Near-Infrared Spectroscopy Scanning for Brain Hematoma Screening • MED.00130 Surface Electromyography Devices for Seizure Monitoring • MED.00131 Electronic Home Visual Field Monitoring • MED.00133 Ingestion Event Monitors • MED.00134 Non-invasive Heart Failure and Arrhythmia Management and Monitoring System. • MED.00137 Eye Movement Analysis Using Non-spatial Calibration for the Diagnosis of Concussion • RAD.00044 Magnetic Resonance Neurography • RAD.00052 Positional MRI • RAD.00057 Near-Infrared Coronary Imaging and Near-Infrared Intravascular Ultrasound Coronary Imaging

• RAD.00061 PET/MRI
• RAD.00063 Magnetization-Prepared Rapid Acquisition Gradient Echo Magnetic Resonance Imaging (MPRAGE MRI)
• SURG.00044 Breast Ductal Examination and Fluid Cytology Analysis • SURG.00053 Unicondylar Interpositional Spacer • SURG.00056 Transanal Radiofrequency Treatment of Fecal Incontinence • SURG.00073 Epiduroscopy • SURG.00075 Intervertebral Stabilization Devices
• SURG.00076 Nerve Graft after Prostatectomy • SURG.00079 Nasal Valve Suspension • SURG.00089 Self-Expanding Absorptive Sinus Ostial Dilation • SURG.00097 Scoliosis Surgery • SURG.00099 Convection Enhanced Delivery of Therapeutic Agents to the Brain • SURG.00102 Artificial Anal Sphincter for the Treatment of Severe Fecal Incontinence • SURG.00105 Bicompartmental Knee Arthroplasty • SURG.00125 Radiofrequency and Pulsed Radiofrequency Treatment of Trigger Point Pain • SURG.00128 Implantable Left Atrial Hemodynamic Monitor • SURG.00134 Interspinous Process Fixation Devices • SURG.00138 Laser Treatment of Onychomycosis • SURG.00146 Extracorporeal Carbon Dioxide Removal • SURG.00147 Synthetic Cartilage Implant for Metatarsophalangeal Joint Disorders • SURG.00149 Percutaneous Ultrasonic Ablation of Soft Tissue • SURG.00153 Cardiac Contractility Modulation Therapy • SURG.00155 Cryoneurolysis • SURG.00156 Implanted Artificial Iris Devices • SURG.00159 Focal Laser Ablation for the Treatment of Prostate Cancer • THER-RAD.00012 Electrophysiology-Guided Noninvasive Stereotactic Cardiac Radioablation • TRANS.00009 Lung and Lobar Transplantation

Medical Policy archivals

• MED.00065 Hepatic Activation Therapy (effective January 4, 2023) • REHAB.00003 Hippotherapy (effective January 4, 2023) • SURG.00082 Computer-Assisted Musculoskeletal Surgical Navigational Orthopedic Procedures of the Appendicular System (effective November 17, 2022) • SURG.00098 Mechanical Embolectomy for Treatment of Acute Stroke (effective January 4, 2023)

Medical Policies and Clinical Guidelines conversions and transitions

Effective November 17, 2022 • CG-MED-63 Treatment of Hyperhidrosis converted to CG-SURG-116 Surgical Treatment of Hyperhidrosis

Effective December 28, 2022 • CG-GENE-07 BCR-ABL Mutation Analysis merged into CG-GENE-14 Gene Mutation Testing for Cancer Susceptibility and Management • CG-GENE-17 RET Proto-oncogene Testing for Endocrine Gland Cancer Susceptibility merged into CG-GENE-14 Gene Mutation Testing for Cancer Susceptibility and Management • CG-GENE-23 Genetic Testing for Heritable Cardiac Conditions merged into CG-GENE-13 Genetic Testing for Inherited Diseases and GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • GENE.00033 Genetic Testing for Inherited Peripheral Neuropathies merged into CG-GENE-13 Genetic Testing for Inherited Diseases • GENE.00037 Genetic Testing for Macular Degeneration merged into GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling and CG-GENE-13 Genetic Testing for Inherited Diseases
• GENE.00038 Genetic Testing for Statin-Induced Myopathy merged into CG-GENE-13 Genetic Testing for Inherited Diseases
• GENE.00039 Genetic Testing for Frontotemporal Dementia (FTD) merged into CG-GENE-13 Genetic Testing for Inherited Diseases

Effective January 4, 2023

• MED.00099 Navigational Bronchoscopy converted to CG-MED-93 Navigational Bronchoscopy

Clinical Guideline de-adoption effective January 1, 2023

• CG-SURG-05 Maze Procedure

MCG updates effective December 9, 2022

W0044 Sympathectomy by Thoracoscopy or Laparoscopy • Revised note under Clinical Indications for Procedure: For surgical treatment of hyperhidrosis, see CG-SURG-116 Surgical Treatment of Hyperhidrosis

W0081 Knee Arthroplasty, Total • Removed reference to note for SURG.00082 Computer-Assisted Musculoskeletal Surgical Navigational Orthopedic Procedures of the Appendicular System

W0105 Hip Arthroplasty • Removed reference to note for SURG.00082 Computer-Assisted Musculoskeletal Surgical Navigational Orthopedic Procedures of the Appendicular System

MCG Content Patch 26.1 updates

Effective May 1, 2023, we will implement the MCG Care Guidelines Content Patch 26.1 Updates for the following modules: General Recovery Care (GRG), Inpatient & Surgical Care (ISC), Behavioral Health Care (BHG). The below information highlights the changes.

• Updated Hemodynamic Instability Definition o Hemodynamic Instability Definition “Pop-up Box” update for multiple guidelines o Hemodynamic Instability Definition “Inline” update for the following General Recovery Care (GRG) guidelines: − CG-GAC General Admission Criteria − CG-PAC Pediatric General Admission Criteria − W0074 Medical Oncology GRG − PG-MDX Multiple Illness GRG • Revised Threshold Lactate Levels for the following Inpatient & Surgical Care (ISC) guidelines: o M-575 Ventricular Arrhythmias o CCC-005 Arrhythmia: Common Complications and Conditions o CCC-019 Hemodynamic Instability: Common Complications and Conditions • MCG Content Patch 26.1 update with additional customization to clarify theta burst stimulation for the following Behavioral Health Care (BHG) guideline: o W0174 Transcranial Magnetic Stimulation − Added Theta burst stimulation (TBS) is considered not medically necessary for all indications

The complete list of our Medical Policies and Clinical UM Guidelines may be accessed on the Anthem Blue Cross Web site at http://www.anthem.com/ca and then select “For Providers”, then choose “Policies, Guidelines & Manuals” under the Provider Resources column, select “Change State” and choose California, scrolling down to select “View Medical Policies & Clinical UM Guidelines”, then select ”Full List page” or by entering a keyword or code in the search box.

We thank you for your continued efforts on behalf of our members and your partnership toward improved access to quality health care for Californians.

Sincerely,

John Yao, MD, MPH, MBA, MPP, FACP Chief Medical Officer

Attachment A – Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-BEH-02 Adaptive Behavioral Treatment • Added Developmental Individual Difference, Relationship- based (DIR/Floortime) Model from CG-BEH-15.
• Discussion/General Information, Definitions, References and Index sections updated. CG-BEH-15 Activity Therapy for Autism Spectrum Disorders and Rett Syndrome • Moved Developmental Individual Difference, Relationship- based (DIR/Floortime) Model to CG-BEH-02 CG-DME-44 Electric Tumor Treatment Field (TTF) • Added Medically Necessary criteria for recurrent glioblastoma multiforme • Revised compliance requirement Medically Necessary criteria from 18 hours per day to 18 hours per day, on average • Revised reference to see rationale for discussion about tumor progression criteria without change in intent CG-GENE-13 (AIM Genetic Testing) Genetic Testing for Inherited Diseases (SB 535 exclusion applies) • Revised the Medically Necessary criteria for preconception or prenatal genetic screening of a parent or prospective parent criterion C based on family history to add: “or one parent or prospective parent is a known carrier of” • Moved content from CG-GENE-23 Genetic Testing for Heritable Cardiac Conditions, GENE.00033 Genetic Testing for Inherited Peripheral Neuropathies, GENE.00037 Genetic Testing for Macular Degeneration (partial content), GENE.00038 Genetic Testing for Statin-induced Myopathy, and GENE.00039 Genetic Testing for Frontotemporal Dementia (FTD) into this document • Added CPT and HCPCS codes 81324, 81325, 81326, 81328, 81414, S3861, S3865 and genes to Tier 2 codes from the documents listed above; also, some additional genes added to Tier 2 and NOC codes • Added 0355U effective January 1, 2023, for APOL1 testing considered Not Medically Necessary CG-GENE-14 (AIM Genetic Testing) Gene Mutation Testing for Cancer Susceptibility and Management (SB 535 exclusion applies) • Moved content from CG-GENE-07 BCR-ABL Mutation Analysis and CG-GENE-17 RET Proto-oncogene Testing for Endocrine Gland Cancer Susceptibility into this document • Added CPT and HCPCS codes 81170 and S3840 and additional genes to Tier 2 codes from documents listed above CG-MED-93 Navigational Bronchoscopy • Moved content from MED.00099 Navigational Bronchoscopy
• Added Medically Necessary criteria for navigational bronchoscopy • Revised Investigational and Not Medically Necessary statement to Not Medically Necessary when criteria not met CG-SURG-03 Blepharoplasty, Blepharoptosis Repair, and Brow Lift • Reorganized the order of the Clinical Indications section • Revised the occlusion amblyopia Medically Necessary statement • Added “for visual field defects” to both the blepharoplasty and blepharoptosis repair Medically Necessary statements • Revised hierarchy for the Medically Necessary criteria re: pre- taping impairment • Added “unilateral or bilateral upper eyelid” to the blepharoptosis repair Medically Necessary statement • Revised Not Medically Necessary statement to address when other criteria have not been met • Removed CPT code 00103 for associated anesthesia not addressed

CG-SURG-49 Endovascular Techniques (Percutaneous or Open Exposure) for Arterial Revascularization of the Lower Extremities • Added HCPCS codes C7531, C7534, C7535 effective January 1, 2023, for revascularization of femoral, popliteal arteries, Medically Necessary when criteria are met CG-SURG-63 Cardiac Resynchronization Therapy with or without an Implantable Cardioverter Defibrillator for the Treatment of Heart Failure • Added HCPCS codes C7538, C7539, C7540 effective January 1, 2023, when related to cardiac resynchronization therapy, Medically Necessary when criteria are met CG-SURG-83 Bariatric Surgery and Other Treatments for Clinically Severe Obesity • Revised reference to children and adolescent section to reflect name of section • Added CPT codes 43290 and 43291 effective January 1, 2023, for intragastric balloon considered Investigational and Not Medically Necessary • Added CPT code 64999 replacing 0312T-0317T deleted effective January 1, 2023, when specified as vagal blocking (VBLOC) considered Investigational and Not Medically Necessary • Removed CPT code 00797 for associated anesthesia not addressed CG-SURG-111 Open Sacroiliac Joint Fusion • Revised descriptor for CPT code 27280
CG-SURG-116 Surgical Treatment of Hyperhidrosis • Moved content from CG-MED-63 Treatment of Hyperhidrosis
• Change of category and addition of "surgical" to title
• Moved content related to iontophoresis to CG-MED-28 Iontophoresis ADMIN.00001 Medical Policy Formation • Revised text related to review and authorization of documents developed by external entities DME.00011 Electrical Stimulation as a Treatment for Pain and Other Conditions: Surface and Percutaneous Devices • Added new CPT codes 0766T, 0767T, 0768T, 0769T, 0783T effective January 1, 2023, for transcutaneous electromagnetic pulse stimulation and transcutaneous auricular neurostimulation, considered Investigational and Not Medically Necessary DME.00048 Virtual Reality-Assisted Therapy Systems • Added new CPT codes 0770T, 0771T, 0772T, 0773T, 0774T effective January 1, 2023, for services using virtual reality technology, considered Investigational and Not Medically Necessary GENE.00010 Panel and other Multi-Gene Testing for Polymorphisms to Determine Drug-Metabolizer Status • Added CPT code 81418 effective January 1, 2023, for drug metabolism panel, considered Investigational and Not Medically Necessary GENE.00049 Circulating Tumor DNA Panel Testing (Liquid Biopsy) (SB 535 exclusion applies) • Added CPT code 0356U effective January 1, 2023, for NavDx® test considered Investigational and Not Medically Necessary GENE.00056 Gene Expression Profiling for Bladder Cancer • Added CPT code 0363U effective January 1, 2023, for Cxbladder Triage test considered Investigational and Not Medically Necessary LAB.00011 Selected Protein Biomarker Algorithmic Assays (SB 535 exclusion applies) • Added CPT code 0360U effective January 1, 2023, for Nodify CDT test considered Investigational and Not Medically Necessary LAB.00033 Protein Biomarkers for the Screening, Detection and Management of Prostate Cancer* (SB 535 exclusion applies) • Added CPT code 0359U effective January 1, 2023, for IsoPSA test, considered Investigational and Not Medically Necessary
LAB.00046 Testing for Biochemical Markers for Alzheimer's Disease • Added CPT codes 0358U for Lumipulse G βAmyloid Ratio and 0361U for Neurofilament Light Chain (NfL) tests effective January 1, 2023, considered Investigational and Not Medically Necessary

MED.00140 Gene Therapy for Beta Thalassemia • Removed umbilical cord blood and haploidentical donor from note to criterion B in Medically Necessary statement • Removed prior malignancy from criterion D in Medically Necessary statement. MED.00142 Gene Therapy for Cerebral Adrenoleukodystrophy • Revised note in Position Statement related to suitable donor RAD.00036 MRI of the Breast • Updated the Position Statement and changed “male relative” to “relatives with XY chromosomes”; “breast abnormality” to “microcalcification”
• Reordered Investigational and Not Medically Necessary bullets SURG.00010 Treatments for Urinary Incontinence • Removed intermittent self-catheterization from note in Medically Necessary statement SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting • Added HCPCS codes Q4236, Q4262, Q4263, Q4264 effective January 1, 2023, for products considered Investigational and Not Medically Necessary SURG.00023 Breast Procedures; including Reconstructive Surgery, Implants and Other Breast Procedures • Added chest wall reconstruction with flat chest closure to the list of surgical procedures considered ‘Reconstructive’ following surgery for breast cancer • Added CPT code 17999 with reconstructive criteria when specified as flat chest closure SURG.00079 Nasal Valve Repair • Added new CPT code 30469 effective January 1, 2023, for Vivaer procedure, considered Investigational and Not Medically Necessary SURG.00095 Viscocanalostomy and Canaloplasty • Revised descriptors for CPT codes 66174, 66175 SURG.00113 Artificial Retinal Devices • Removed HCPCS codes C1841, C1842 deleted December 31, 2022, for Argus II removed from market SURG.00140 Peripheral Nerve Blocks for Treatment of Neuropathic Pain • Revised descriptors for CPT codes 64415, 64417, 64447 THER-RAD.00012 Electrophysiology-Guided Noninvasive Stereotactic Cardiac Radioablation • Added new CPT codes 0745T, 0746T, 0747T effective January 1, 2023, for cardiac radioablation services considered Investigational and Not Medically Necessary; replacing non-specific radiation therapy codes (77299, 77399) TRANS.00013 Small Bowel, Small Bowel/Liver, and Multivisceral Transplantation • Added the term “multivisceral” and the phrase, “including but not limited to treatment of pseudotumor peritonei” to the first Investigational and Not Medically statement • • Removed the third INV&NMN on “all other multivisceral transplants” TRANS.00024 Hematopoietic Stem Cell Transplantation for Select Leukemias and Myelodysplastic Syndrome • Revised the Medically Necessary criteria for Acute Myeloid Leukemia to remove “favorable classification” as required criteria and replaced the required criteria with the specific conditions considered favorable classification without a change in intent

TRANS.00029 Hematopoietic Stem Cell Transplantation for Genetic Diseases and Aplastic Anemias • Expanded scope of document to address autologous hematopoietic stem cell mobilization and pheresis for the treatment of genetic diseases as part of the development of an FDA-approved ex vivo gene therapy (for example, betibeglogene autotemce or elivaldogene autotemcel) • Added Medically Necessary and Investigational and Not Medically Necessary criteria for Autologous hematopoietic stem cell mobilization and pheresis • Revised list of ICD-10-CM diagnosis codes for which autologous pheresis/stem cell harvesting would be considered Investigational and Not Medically Necessary to exclude diagnoses related to gene therapy TRANS.00035 Therapeutic use of Stem Cells, Blood and Bone Marrow Products • Added CPT Category III code 0748T effective January 1, 2023, for injection of stem cell product into perianal perifistular soft tissue considered Investigational and Not Medically Necessary